Specifying the anti-inflammatory effects of ziltivekimab with diverse imaging modalities and in-depth cellular phenotyping

Phase 2

• Conditions: Atherosclerosis; low-grade inflammation; 10011082; 10003216

• Registration Number: NL-OMON53495
• Lead Sponsor: Vasculaire Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Aged 50 years and older.
- Multi-vessel coronary artery disease (defined as CAD-RADS >=2 and/or PAV/NCPV
stage >=2).
- Serum hsCRP level >=2 mg/L.

Exclusion Criteria

- Coronary stents in situ.
- Chronic or recent (<1 month) (serious) infections and/or clinical signs of
acute (serious) infection.
- History of severe auto-immune diseases, or other (severe) (recurrent or
chronic) inflammatory disorders.
- Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or
positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus
(HIV) not on stable antiretroviral regimen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is the mean percentage change in coronary arteries target to<br /><br>background ratio (TBRmax) and monocyte activation marker protein expression<br /><br>between the treatment and placebo group, at the primary analysis time point of<br /><br>20 weeks, compared to baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Imaging:<br /><br>• Difference in PCAT (CCTA derived) after ziltivekimab treatment.<br /><br>• Correlation between changes in coronary 68Ga-DOTATATE uptake and anatomical<br /><br>plaque changes on CCTA.<br /><br>• Difference in 68Ga-DOTATATE SUVmax of bone marrow and spleen after treatment.<br /><br>• Difference in 68Ga-DOTATATE TBRmax of ascending aorta after treatment.<br /><br><br /><br>Inflammation and proteomics:<br /><br>• The impact of ziltivekimab on monocyte phenotype in transendothelial<br /><br>migration (TEM) capacity and transcriptome profile.<br /><br>• The mean percentage change in plasmatic proteins before and after<br /><br>ziltivekimab treatment.<br /><br>• The impact of ziltivekimab on inflammation in plasma cytokine and chemokine<br /><br>levels.</p><br>